| (F) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for issuance and
renewal of a license and the issuance of an amended license.
(G) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(H) An ASC pharmacy, licensed under the Act, §560.051(a)(3),
concerning institutional pharmacy (Class C), which also operates another
type of pharmacy which would otherwise be required to be licensed
under the Act, §560.051(a)(1), concerning community pharmacy
(Class A), or the Act, §560.051(a)(2), concerning nuclear pharmacy
(Class B), is not required to secure a license for the other type
of pharmacy; provided, however, such license is required to comply
with the provisions of §291.31 of this title (relating to Definitions), §291.32
of this title (relating to Personnel), §291.33 of this title
(relating to Operational Standards), §291.34 of this title (relating
to Records), and §291.35 of this title (relating to Official
Prescription Requirements), or §291.51 of this title (relating
to Purpose), §291.52 of this title (relating to Definitions), §291.53
of this title (relating to Personnel), §291.54 of this title
(relating to Operational Standards), and §291.55 of this title
(relating to Records), contained in Nuclear Pharmacy (Class B), to
the extent such sections are applicable to the operation of the pharmacy.
(I) An ASC pharmacy engaged in the compounding of non-sterile
preparations shall comply with the provisions of §291.131 of
this title.
(J) ASC pharmacy personnel shall not compound sterile
preparations unless the pharmacy has applied for and obtained a Class
C-S pharmacy license.
(K) An ASC pharmacy engaged in the provision of remote
pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.121 of this title
(relating to Remote Pharmacy Services).
(L) An ASC pharmacy engaged in centralized prescription
dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.123 of this title (relating
to Central Prescription Drug or Medication Order Processing) and/or §291.125
of this title (relating to Centralized Prescription Dispensing).
(2) Environment.
(A) General requirements.
(i) Each ambulatory surgical center shall have a designated
work area separate from patient areas which shall have space adequate
for the size and scope of pharmaceutical services and shall have adequate
space and security for the storage of drugs.
(ii) The ASC pharmacy shall be arranged in an orderly
fashion and shall be kept clean. All required equipment shall be clean
and in good operating condition.
(B) Special requirements.
(i) The ASC pharmacy shall have locked storage for
Schedule II controlled substances and other controlled drugs requiring
additional security.
(ii) The ASC pharmacy shall have a designated area
for the storage of poisons and externals separate from drug storage
areas.
(C) Security.
(i) The pharmacy and storage areas for prescription
drugs and/or devices shall be enclosed and capable of being locked
by key, combination, or other mechanical or electronic means, so as
to prohibit access by unauthorized individuals. Only individuals authorized
by the pharmacist-in-charge may enter the pharmacy or have access
to storage areas for prescription drugs and/or devices.
(ii) The pharmacist-in-charge shall consult with ASC
personnel with respect to security of the drug storage areas, including
provisions for adequate safeguards against theft or diversion of dangerous
drugs and controlled substances, and to security of records for such
drugs.
(iii) The pharmacy shall have locked storage for Schedule
II controlled substances and other drugs requiring additional security.
(3) Equipment and supplies. Ambulatory surgical centers
supplying drugs for postoperative use shall have the following equipment
and supplies:
(A) data processing system including a printer or comparable
equipment;
(B) adequate supply of child-resistant, moisture-proof,
and light-proof containers; and
(C) adequate supply of prescription labels and other
applicable identification labels.
(4) Library. A reference library shall be maintained
that includes the following in hard copy or electronic format and
that pharmacy personnel shall be capable of accessing at all times:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules;
(iv) Federal Controlled Substances Act and rules or
official publication describing the requirements of the Federal Controlled
Substances Act and rules;
(B) at least one current or updated general drug information
reference which is required to contain drug interaction information
including information needed to determine severity or significance
of the interaction and appropriate recommendations or actions to be
taken; and
(C) basic antidote information and the telephone number
of the nearest regional poison control center.
(5) Drugs.
(A) Procurement, preparation, and storage.
(i) The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from
other appropriate staff of the facility, relative to such responsibility.
(ii) The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(iii) ASC pharmacies may not sell, purchase, trade,
or possess prescription drug samples, unless the pharmacy meets the
requirements as specified in §291.16 of this title (relating
to Samples).
(iv) All drugs shall be stored at the proper temperatures,
as defined in the USP/NF and in §291.15 of this title (relating
to Storage of Drugs).
(v) Any drug bearing an expiration date may not be
dispensed or distributed beyond the expiration date of the drug.
(vi) Outdated drugs shall be removed from dispensing
stock and shall be quarantined together until such drugs are disposed
of.
(B) Formulary.
(i) A formulary may be developed by an appropriate
committee of the ASC.
(ii) The pharmacist-in-charge or consultant pharmacist
shall be a full voting member of any committee which involves pharmaceutical
services.
(iii) A practitioner may grant approval for pharmacists
at the ASC to interchange, in accordance with the facility's formulary,
for the drugs on the practitioner's medication orders provided:
(I) a formulary has been developed;
(II) the formulary has been approved by the medical
staff of the ASC;
(III) there is a reasonable method for the practitioner
to override any interchange; and
(IV) the practitioner authorizes a pharmacist in the
ASC to interchange on his/her medication orders in accordance with
the facility's formulary through his/her written agreement to abide
by the policies and procedures of the medical staff and facility.
(C) Prepackaging and loading drugs into automated medication
supply system.
(i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities suitable
for distribution to other Class C pharmacies under common ownership
or for internal distribution only by a pharmacist or by pharmacy technicians
or pharmacy technician trainees under the direction and direct supervision
of a pharmacist.
(II) The label of a prepackaged unit shall indicate:
(-a-) brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(-b-) facility's lot number;
(-c-) expiration date;
(-d-) quantity of the drug, if quantity is greater
than one; and
(-e-) if the drug is distributed to another Class C
pharmacy, name of the facility responsible for prepackaging the drug.
(III) Records of prepackaging shall be maintained to
show:
(-a-) the name of the drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged unit;
(-g-) number of prepackaged units;
(-h-) date packaged;
Cont'd... |
